DIABSMART Report Summary

Final Report Summary - DIABSMART (Development of a new generation of DIABetic footwear using an integrated approach and SMART materials.)

Background (Overall aim and objectives)

DiaBSmart project has aimed to generate, transfer and exchange the clinical, academic and manufacturing knowledge between the consortium partners to create a new generation of diabetic footwear through a newly developed patient assessment system. The transfer of knowledge (TOK) between academic, industry and clinical sectors has ensured that the needs of patients is considered and transferred effectively to product development using a scientific approach. The objectives included: (1) the design and development of an integrated system of Diabetic foot assessment (2) to validate the newly developed system using experimental methods (3) to develop a suitable insole material to meet the mechanical and clinical requirements (4) to evaluate the mechanical and clinical effectiveness of material choice in reducing the potential risk of foot complications.

Scientific and Technological Outcomes, Knowledge Generation:

A Numerical, Experimental and Mathematical Analyses approach that integrates all aspects of diabetic footwear including; clinical and biomechanical dimensions was developed. This was adopted to determine the most suitable material properties for the insole that can promote favourable pressure distribution underneath the foot to prevent injuries i.as a result of mechanical trauma i.e. ulcers. The selection process enables a new generation of diabetic insole, for which the mechanical properties can be optimised based on patients weight and foot strike pattern during physical activity.

Furthermore the influence of other individual parameters including plantar soft tissue stiffness and thickness were also incorporated into the selection process. This has shown to minimise/ redistribute the pressure and hence the stress on the soft tissue in the critical plantar areas of the foot, hence decreasing the likelihood of mechanical trauma during activities of daily living for diabetic neuropathic patients.

Main results achieved so far:

The Numerical, Experimental and Mathematical Analyses (NEMA) approach that was developed in this project has integrated all aspects of diabetic footwear including; clinical and biomechanical assessment, material choice and aesthetic design. This interdisciplinary approach has incorporated the areas of clinical biomechanics and material science. The innovative content of the developed system is the smart selection of insole material for which its mechanical properties are optimised for each individual.

The results emphasised the importance and necessity of individualised approach to insole material selection for diabetic neuropathic patients at risk of foot ulceration. This information has shown to have practical implications in stratified approach to material selection for patients and with regards to customisation of the material properties with optimised cushioning ( as being not too stiff neither too soft) to facilitate an appropriate pressure distribution.

The system has been validated against experimental methods in which the results from numerical analyses were compared against the plantar pressure that is the interface pressure between the foot and the insole. The former was measured experimentally in a trial and error setting in which the plantar pressure is measured while different insoles with different stiffness levels were tested.

The customisation of insole material properties was achieved through combining different components of the Polyurethane (PU) foam that was a commonly used material in diabetic insole This has enabled the customisation of cushioning material properties while at the same time allowed the use of conventional injection moulding facilities that are common in the area of footwear manufacturing across Europe.Proposed interdisciplinary, inter-sectorial approach has been unique and brought together the expertise from research institutions, industry and clinical sector. The transfer of knowledge between these sectors has ensured the synergy and efficient use of information in patient assessment, monitoring, product development and customisation in an objective fashion.

Expected final results and their potential impact and use:

This project has substantially enhanced the knowledge base in the area of diabetic foot assessment and footwear prescription, and has shown to have a clear impact on the selection of insole materials for diabetic neuropathic patients, which in turn can result in a better health outcome. This project has been a cross-sector collaboration that combined the technical and scientific expertise of the two academic institutions, along with the clinical expertise with the production, design and manufacturing experience available in the industry.

This has resulted in a synergetic approach in customising the cushioning properties of insole materials for people with diabetic neuropathy based on the individual patient’s biomechanical requirements. While the partners in the consortium have collaborated extensively and have established an excellent working relationship during this project, it is expected the clinical biomechanics group act as a research and development hub in the immediate future.

In this hub the needs of the clinical sector will be translated to the capacities in the healthcare industry in the area of diabetic foot care and footwear provision. It is expected that these industry-academia partnership and collaboration will gain visibility and competitiveness worldwide, which will result in a better footcare for people with diabetes in future.

Intensified by DiabSmart project Staffordshire University has already been involved in a number of other smaller projects in the area of diabetic footwear. In these projects that are funded through national funding bodies (in the UK) a better care for diabetic foot patients is proposed through the introduction of innovative insoles (i.e. 3D printed insoles and matrix structures). These collaborations were culminated in the manufacturing of a new generation of custom designed products with an improved capability of protecting the foot and facilitating walking for diabetic population.

StaffsUni (the coordinator) acted as a hub for developing and implementation of the training and networking activities which has shown to promote and reinforce the industry-academia dialogue. As a result of cross pollination between DiabSmart project and the postgraduate courses in Clinical Biomechanics, a new course (Postgraduate Certificate in “Mechanics of the Diabetic Foot” and a bespoke module “Diabetic Foot Biomechanics” have been introduced. These education and training programme proved to be popular with the allied health professionals and scientists alike. Furthermore these courses are also being offered as shorter training courses with popularity among diabetic foot and tissue viability nurses with possible demand at international level.

In terms of human resources, this project has shown to be an important vehicle for enhancing the researcher’s knowledge capabilities and qualities through specific research training and exposure to research environment that has paved the way for their future employment in academic, clinical and industry sector.

Overall, this project was inclusive in terms of (1) scientific/ academic capability of fellows - ranging from low level academic qualifications to doctoral level qualifications (2) gender bias - we had 7 females and 6 males along with a equal mix of genders within the wider team and the research environment (3) ethnicity - the nature of this project enabled us to include fellows from all backgrounds.

In short DiabSmart project has also lead to a fruitful collaboration between academia and healthcare industry that is turn can promise a new level of healthcare for people with diabetes and neuropathy.This has culminated in the employment of clinically viable biomechanical measures in the diabetic foot clinic at AR Hospital that in turn promoted a better foot care for diabetic neuropathic patients. In addition to the number of joint publications that are co-authored by the clinicians and scientists in the project, the transfer of knowledge has led to a more comprehensive and all inclusive foot care for patients.